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Thông tin tác giả Greenlight Guru + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory, Greenlight Guru + Medical Device Entrepreneurs, and Consultants; R được phát hiện bởi Player FM và cộng đồng của chúng tôi - bản quyền thuộc sở hữu của nhà sản xuất (publisher), không thuộc về Player FM, và audio được phát trực tiếp từ máy chủ của họ. Bạn chỉ cần nhấn nút Theo dõi (Subscribe) để nhận thông tin cập nhật từ Player FM, hoặc dán URL feed vào các ứng dụng podcast khác.

What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests with UDI experience. You’ll learn a lot about UDI and learn where to find some fantastic resources that can increase your knowledge.

Laura Maher and Brittani Smith are both Medical Device Gurus and Greenlight Gurus. Their jobs involve guiding companies through regulations and quality requirements and challenges unique to MedTech companies and medical device professionals, and UDI is among those challenges. Both Brittani and Laura bring a wealth of experience and knowledge to the topic.

Listen to the episode to learn the difference between device identifiers and product identifiers, the process of getting a UDI and applying it, then going on with the registration process, and how to think about the UDI requirements that are coming into effect.

Some of the highlights of this episode include:

  • What UDI is and the difference between the device identifier and the product identifier
  • Physical applications of UDI
  • The leading zeros and what they mean for packaging
  • The process flow of getting the UDI, applying the UDI, and registering the device
  • Challenges with bar code verification
  • Tips for manufacturers going through UDI implementation
  • Uploading to GUDID
  • Why the UDI requirement is in place
  • The different acronyms involved in UDI
  • The importance of finding and using the resources available to you

Memorable quotes from this episode:

FDA doesn’t set a specification for what your bar code quality should be, but depending on who you’re using, your GS1 specifically, they have standards for what the quality of their bar code should be.” –Laura Maher

“Just like Laura, I became a little bit of a UDI expert at the company, just because I got to learn the ins and the outs of it.” –Brittani Smith

“You’ve got to be careful about contrast and the color that you’re using for your bar code.” –Laura Maher

“For your surgeons and your patients, the end users, the biggest thing is safety.” -Brittani Smith

Links:

Brittani Smith LinkedIn

Laura Maher LinkedIn

GS1

UDI with Gary Saner

Greenlight Guru Ultimate Guide to UDI

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru

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